510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K940927Substantially Equivalent

Rescue Breather

O-Two Systems Intl., Inc., Mississauga, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K940927 is the FDA 510(k) clearance record for RESCUE BREATHER, a class II device, cleared for O-Two Systems Intl., Inc. on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list 14 510(k) clearances for O-Two Systems Intl., Inc., from to . As of , FDA records show no recalls naming K940927.

Clearance record

Decision date
Received
(228 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
O-Two Systems Intl., Inc. 7575 Kimbel St., Mississauga, CA
510(k) summary
Statement
Third party review
No

Clearances, product code CBP

Trailing 12 months

FDA records hold no clearances under product code CBP in the trailing twelve months.

FDA records show no clearances under product code CBP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260